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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000627

Date: June 26, 2006

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

Subject: FCN No. 627 - Copolymer of styrene and butadiene having a styrene polymer unit content of 60% to 74% for use in food contact articles.

Notifier: CPChem Company, L.P.
c/o Keller and Heckman, LLP
Washington, D.C., USA

To: Division of Food Contact Notifications (HFS-275)
Attention: Anita Chang, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 627. When this notification becomes effective, these documents and the notifier's revised EA dated May 24, 2006, may be made available to the public, and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

Please let us know if there is any change in the identity or use of the food-contact substance.

Katrina E. White, Ph.D.

2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 627



 


 

Finding of No Significant Impact

A food contact notification (FCN No. 627), submitted by Chevron Phillips Chemical Company L.P., to provide for the safe use of a copolymer of styrene and butadiene, having a styrene polymer unit content of 60% to 74%, as a component in the manufacture of articles intended to contact food. The food contact substance is intended to contact all types of food under conditions of use A through H, as described in Table 2 of 21 CFR 176.170(c).

The Environmental Review Group has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in the notification, including a revised environmental assessment dated May 24, 2006, and our supplement to the environmental record.

Prepared by __________________________________________Date: June 26, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: June 26, 2006
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


 

Supplement to the Environmental Information
for Food Contact Notification No. 627

This document incorporates by reference the notifier's revised environmental assessment(EA) dated May 24, 2006.

The purpose of this supplement is to ensure the accuracy and completion of the environmental record to assist the public in understanding the agency's basis for preparing a finding of no significant impact.

Item 4. Description of the Proposed Action

The EA did not provide information on the anticipated use of the food-contact substance (FCS). However, the notifier stated elsewhere in the food-contact notification, "The types of finished articles the FCS will be used to make include (1) bulk food storage bins to hold candy, nuts, dry cereal, etc.; (2) cups, pitchers, and tumblers; (3) food processing accessories, such as blenders, to process dairy, vegetables, and fruits; (4) single use service ware for desserts, beverages, and deli and vegetable trays; and (5) refrigerator crisper drawers that will be used to hold raw vegetables and fruit. The FCS also will be used in non-food applications, such as in toys, medical equipment, and consumer goods."

Item 7. Fate of Emitted Substances in the Environment.

Under Format Item 7, the EA states, "The products of complete combustion of the resin would be carbon dioxide and water; the concentrations of these substances in the environment will not be significantly altered by the proper incineration of the polymers in the amounts utilized for food-contact applications." Although properly operating incinerators substantially reduce the quantity of emissions from waste combustors, they do not completely eliminate them because some incomplete combustion still occurs (Paul M. Sullivan; Hallenbeck, W. H.; Brenniman, G. R. Municpal Solid Waste Combustion; University of Illinois at Chicago: Chicago, IL, 1993). The molecular structure of the FCS and the confidential market volume show that 1) the FCS will make up a very small portion of the total municipal solid waste currently combusted (estimated to be 33 million tons or 14% of 236 million tons in 2003) and 2) the FCS will not significantly alter emissions from properly operating municipal solid waste combustors (U.S. EPA Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2003; EPA530-F-05-003; 2005). Further, combustion of the FCS in incinerators will not affect compliance with the U.S. Environmental Protection Agency regulations for incinerators (40 CFR Part 264). Consequently, emissions released due to the proposed use of the FCS will not significantly affect the quality of the human environment.

Under Format Item 7, the EA also states, "No significant quantities of any substance will be added to these water systems upon the proper incineration of the polymer, nor upon its disposal in landfills due to the extremely low levels of aqueous migration of the polymer components." We do not agree completely with this statement. The main reason that the fate of the FCS in the aqueous environment did not need to be addressed is because no significant introductions of substances into the environment were identified under Format Item 6.

Item 9. Use of Resources and Energy

One relevant environmental concern for polymeric packaging is the potential impact it could have on the current recycling of single use beverage bottles. To address this concern, the notifier provided a complete description of the proposed uses of the FCS and cost and technical information on rigid packaging composed of the FCS in a confidential attachment to the notification. This supported the claim that the FCS was unlikely to be used as a replacement of polymers used to make single use beverage bottles that are recycled at high rates. Therefore, no evidence suggests that this FCS is anticipated to replace rigid packaging that is recycled at high rates; we believe that the proposed use of the FCS will not have a significant impact on the use of resources and energy.

Prepared by __________________________________________Date: June 26, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.